Device Classification Name |
system, peritoneal, automatic delivery
|
510(k) Number |
K844144 |
Device Name |
SCD STERILE CONNECTION DEVICE |
Applicant |
E.I. DUPONT DE NEMOURS & CO., INC. |
MEDICAL PRODUCTS DEPARTMENT |
BARLEY MILL PLAZA, P22-1170 |
WILMINGTON,
DE
19898
|
|
Applicant Contact |
ANN F NICHOLAS |
Correspondent |
E.I. DUPONT DE NEMOURS & CO., INC. |
MEDICAL PRODUCTS DEPARTMENT |
BARLEY MILL PLAZA, P22-1170 |
WILMINGTON,
DE
19898
|
|
Correspondent Contact |
ANN F NICHOLAS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 10/23/1984 |
Decision Date | 11/16/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|